US FDA Strategy On Abuse-Deterrent Opioids Needs Rethinking, Panelists Say
Deterring intravenous abuse over other routes of abuse should be agency's priority, some advisory committee members say during discussion of abuse patterns and risks with Endo’s reformulated Opana ER.
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US FDA will survey health care providers’ current understanding of analgesic abuse-deterrent formulations and conduct an experimental study exploring the effectiveness of different terminology and descriptions for such products; agency has heard complaints from its own AdComms about terminology around abuse deterrence.
US FDA advisory committee may not be comfortable with intravenous abuse-deterrence labeling for Rexista (oxycodone extended-release) when the sponsor has not assessed the impact on other routes of abuse purportedly targeted by the formulation.
Data sources and methodologies to evaluate real-world effects of abuse-deterrent formulations will be focus of US FDA public meeting in July; value and feasibility of assessing the public health effects of such products more broadly is up for discussion.